-Wall Street Journal

09/11/2009 - A judge declared a mistrial Friday in a closely watched case involving Merck & Co.'s osteoporosis drug Fosamax after a jury failed to reach a verdict amid tense jury deliberations.

The mistrial came two days after U.S. District Judge John F. Keenan in Manhattan called for a daylong "cooling off" period as one juror claimed in a note to have been the subject of physical threats and that a chair was thrown in the jury room.

The judge declared a mistrial Friday after the jury's forewoman indicated the jury remained deadlocked and a lawyer for Shirley Boles, a 71-year-old Florida woman who sued Merck, again asked for a mistrial. Merck opposed the mistrial motion.

Paul F. Strain, a lawyer for Merck, said the drug maker intends to file a motion in the next few weeks asking the judge to rule in favor of Merck and dismiss the Boles case.

"We regret very much the jury did not continue their deliberations," Strain said. The jury appeared to be "seven-to-one in Merck's favor," he said.

"We will be prepared to defend this case again if a retrial is scheduled," said Bruce N. Kuhlik, executive vice president and general counsel of Merck. "We continue to believe that the company provided appropriate and timely information about Fosamax to consumers and to the medical, scientific and regulatory communities."

Timothy O'Brien, a lawyer for Boles, said he expects the Boles case would likely be retried in the spring. A conference has been scheduled for October.

"For Mrs. Boles, we're going to refine her message, focus a little more on the evidence we have, so we don't have a three- or four-week trial," O'Brien said.

The five-woman, three-man jury began deliberations last week, but first sent out notes on Tuesday indicating they were at an impasse and couldn't come to a consensus on whether Fosamax caused a severe jaw condition, known as osteonecrosis, suffered by Boles.

The judge urged them to continue their deliberations on Tuesday, but tensions apparently continued to remain high.

On Wednesday, one juror said she had been the subject of physical and verbal threats. "I need a police escort out of here - and I am afraid to come back because I can not in good conscience vote for a case because of threats," the juror said in a note.

In a separate note Wednesday, jurors indicated one juror wasn't following the charge and felt "that 'if' Merck knew about the risks that that is enough 'proof' that Fosamax caused Mrs. Boles injury."

The handwritten note, which was signed by seven of the eight jurors, also said the dissenting juror "feels that they have found evidence that supports their view about the risks of Fosamax, but has found no evidence of proof that Fosamax caused her injury."

O'Brien, Boles's lawyer, on Wednesday described the deliberations as "the most brutal deliberation or audible deliberation I, as counsel, have been privy to."

He noted shouting could be heard coming from the jury room several times during deliberations.

The judge then instituted a daylong "cooling off" period, sending the jury home early for the day and offering to have court security officers escort them to the subway.

Merck is facing about 900 cases in state and federal courts generally alleging that use of Fosamax can cause the jaw-destroying condition osteonecrosis, and that Merck failed to properly warn of this risk. The Boles case was the one of the first product-liability cases to go trial.

Much of the litigation is being coordinated by Judge Keenan in Manhattan, where the Boles trial took place.

Osteonecrosis is a condition where the bone dies and can eventually fracture. It can lead to exposed bone in the jaw.

Merck has set aside more than $100 million over the past few years to cover legal-defense costs for Fosamax but hasn't yet created a reserve to cover potential liability.

However, Merck's ultimate Fosamax liability is unlikely to approach the size of the $4.85 billion settlement to which Merck agreed in 2007 to resolve personal-injury litigation over its former Vioxx pain drug - which was linked to increased risk for heart attacks - partly because there are far fewer Fosamax lawsuits.

Fosamax was once one of Merck's best-selling drugs (generating more than $3 billion in annual sales) but it lost U.S. patent protection in 2008, exposing it to cheaper generic competition which has reduced sales of the branded drug substantially.

In his closing statement last week, O'Brien, a lawyer for Boles, argued in part that Merck had failed to notify physicians, including Boles's doctor, or the public of a possible side effect: osteonecrosis. He also said the company failed to investigate cases of osteonecrosis in Fosamax users.

O'Brien also said that Merck misrepresented the benefits of Fosamax for women such as Boles - namely, that it doesn't provide any benefits in terms of preventing osteoporosis.

Strain, a lawyer for Merck, countered in his closing statement last week that Boles, a long-time cigarette smoker, had a history of dental problems and health problems.

Strain said the worst outbreak of her jaw condition was earlier this year - three years after she stopped taking Fosamax. Boles stopped taking the drug in 2006.

For more information about Fosamax side effects visit http://www.fosamax-lawyer.com